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BioWorld - Tuesday, January 27, 2026
Home » Topics » Regulatory » Policy

Policy
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Syringe on map of Africa

Experts cite deadly consequences of PEPFAR funding disruption

April 8, 2025
By Nuala Moran
The extent of the damage that will be caused if the U.S. overseas aid program, the President’s Emergency Plan for AIDS Relief (PEPFAR), is axed or has its funding cut, is laid out in an expert analysis published in The Lancet April 8, which estimates nearly 500,000 children could die from AIDS-related causes by 2030, while 1 million children will be infected with the virus.
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Collection of vials

Much-needed predictability lacking in US biosimilar market

April 8, 2025
By Mari Serebrov
Ill-considered government policies, pharmacy benefit manager market abuses and an unpredictable future are casting doubt on the long-term sustainability of the U.S. biosimilar market, Craig Burton, the executive director of the Biosimilars Council, told a House Ways & Means subcommittee April 8.
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Judge's gavel with US flag

US court says no to NIH indirect rate cut, another suit filed

April 7, 2025
By Mari Serebrov
The nationwide preliminary injunction keeping the U.S. NIH from slashing its indirect cost rate to a flat 15% has become permanent. In issuing the permanent injunction and final judgment April 4 in three challenges to the rate change, Judge Angel Kelley, of the U.S. District Court for the District of Massachusetts, said the NIH’s Feb. 7 notice that it would begin imposing the 15% rate Feb. 10 to all existing and future grants violated the Administrative Procedure Act, as the action was arbitrary and capricious, was impermissibly retroactive and failed to follow notice-and-comment procedures.
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Red dollar sign under microscope

Trump cuts are 'gutting' research grants, 'destabilizing' science

April 4, 2025
By Nuala Moran
“The nation’s scientific enterprise is being decimated.” That statement in an open letter “to the American people” signed by 1,800 members of the U.S. National Academies, is made concrete in a list of 709 NIH grants – and counting – that have been axed since President Donald Trump was inaugurated on Jan. 20.
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DNA testing illustration

With ‘wholesale assault’ on research, bipartisan alarm at institutional failure

April 4, 2025
By Anette Breindl
Biomedical research seems like it should be the ultimate bipartisan issue. But under the Trump administration, unless and until Congress regains its will to make use of its constitutional powers, bipartisan support for research seems to be a thing of the past.
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DNA testing illustration
Policy

With ‘wholesale assault’ on research, bipartisan alarm at institutional failure

April 4, 2025
By Anette Breindl
Biomedical research seems like it should be the ultimate bipartisan issue. But under the Trump administration, unless and until Congress regains its will to make use of its constitutional powers, bipartisan support for research seems to be a thing of the past. On March 3, members of the National Academies of Science, Engineering and Medicine warned that the second Trump administration has been waging a “wholesale assault” on American research.
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Dollar sign, downward arrow

Impact of Trump tariffs on med tech proving difficult to anticipate

April 3, 2025
By Mark McCarty
The Trump administration’s declaration of a new round of tariffs did not sit well with trade associations, but the impact of those tariffs may vary somewhat by company. Analysts said the lack of clarity regarding the impact of tariffs makes it difficult to predict the impact on the device and diagnostics industries, leaving investors and customers alike with a large overhang of uncertainty.
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Gold dollar sign and gray question marks

Tariffs pressure industry markets; uncertainty remains

April 3, 2025
By Karen Carey
President Donald Trump’s executive order on global tariffs have pushed downward the stocks of biopharma and med-tech companies, even though the impacts of his 10% baseline tariff – which excludes pharmaceuticals – and his reciprocal tariffs affecting about 60 countries across the globe, are still unclear. “The story for the day is there’s still a lot of uncertainties in terms of pharmaceuticals,” said Wayne Winegarden, senior fellow and director of the Center for Medical Economics and Innovation at the Pacific Research Institute, a free-market think tank. “It’s going to pressure margins, pressure availability. This is just a complete negative for the industry. It’s self-inflicted. It’s not just unnecessary, it’s unwarranted.”
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Globe isolated on white background with focus on Asia and Australia

Asia in firing line of Trump tariffs, but health care escapes largely unscathed

April 3, 2025
By Tamra Sami
Following news of U.S. President Donald Trump’s 10% across-the-board tariffs on Australian exports to the U.S., Australia’s Securities Exchange shed nearly AU$55 billion in losses Thursday morning. Even so, pharmaceuticals have escaped the tariffs for now. In China, Trump’s tariffs are not a big concern for China’s health care because drugs and active pharmaceutical ingredients are exempted from the tariffs. Even if tariffs are imposed in the future, Chinese pharmaceutical companies have already significantly de-risked themselves in recent months by increasing out-licensing models with U.S. partners.
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DNA testing illustration

With ‘wholesale assault’ on research, bipartisan alarm at institutional failure

April 3, 2025
By Anette Breindl
Biomedical research seems like it should be the ultimate bipartisan issue. But under the Trump administration, unless and until Congress regains its will to make use of its constitutional powers, bipartisan support for research seems to be a thing of the past. On March 3, members of the National Academies of Science, Engineering and Medicine warned that the second Trump administration has been waging a “wholesale assault” on American research.
Read More
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